Clinical trial
A Study of Belimumab in Subjects With Systemic Lupus Erythematosus
NCT00410384 · Human Genome Sciences Inc., Industry · Completed
Key facts
| NCT number | NCT00410384 |
|---|---|
| Title | A Study of Belimumab in Subjects With Systemic Lupus Erythematosus |
| Official title | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 76-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE) |
| Acronym | BLISS-76 |
| Lead sponsor | Human Genome Sciences Inc., Industry |
| Collaborators | GlaxoSmithKline Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Systemic Lupus Erythematosus |
| Intervention type | Drug |
| Interventions | Placebo, Belimumab 1 mg/kg, Belimumab 10 mg/kg |
| Enrollment | 819 |
| Start date | Dec 1, 2006 |
| Primary completion | Sep 1, 2009 |
| Completion | Mar 1, 2010 |
| First posted | Dec 12, 2006 |
| Last update posted | Feb 1, 2017 |
| Countries | Austria, Belgium, Canada, Costa Rica, Czechia, France, Germany, Israel, Italy, Mexico, Netherlands, Poland and 7 more |
At a glance
- 100–999 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: